Events

Retiro De Equipo (Recall) de Baxter Colleague Volumetric Infusion Pumps

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Baxter Healthcare Corporation SA.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    16458
  • Fecha de inicio del evento
    2014-03-28
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Causa
    Potential failure of fuses fitted in the rear housing of the colleague volumetric infusion pump., during 2011 it was identified that a quantity of pumps fitted with two ceramic 1.6a slow-blow fuses in the rear housing was failing prematurely. investigation lead to a change of the fuse type fitted during future manufacture and service, from a ceramic fuse to a glass fuse, which has a different rupture characteristic., the failure rate of this reported issue has subsequently declined following the replacement with a glass fuse.
  • Acción
    Manufacturer to issue advice regarding use

Device

Baxter Colleague Volumetric Infusion Pumps

Manufacturer

Baxter Healthcare Corporation SA